Finding Links Between Hot flASHes and CardioVascular Disease
ConditionMenopause-related Hot Flashes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorMassachusetts General Hospital
About this trial
The goal of this clinical trial is to learn if neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improves blood vessel health in women with moderate to severe hot flashes. The main questions it aims to answer is does neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improve blood vessel health?
Eligibility criteria
Qualifiers
Age 40-65 years
Peri- and post-menopausal women (STRAW -1 to +1)
Moderate or high vasmotor symptom burden
Obesity (body mass index ≥ 30 kg/m2)
Disqualifiers
Inability to provide informed consent or comply with study protocol
Major comorbidities: cancer, end-stage renal (eGFR <45 mL/min/1.73 m2), liver or lung disease
Concomitant use of strong or moderate cytochrome P450 3A4 inhibitors
Elevated liver function tests (ALT, AST, and/or total bilirubin ≥2x ULN)
Trial design
Treatments tested in this trial
- elinzanetant - reference formulation
- placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov